Tolnaftate Cream

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Tolnaftate Cream contains NLT 90.0% and NMT 110.0% of the labeled amount of tolnaftate (C₁₉H₁₇NOS).

2 IDENTIFICATION

Change to read:

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Add the following:

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Change to read:

3.1 Procedure

Solution A: Methanol and water (70:30). To each liter of the solution, add 1 mL of trifluoroacetic acid.

Solution B: Methanol and water (90:10). To each liter of the solution, add 1 mL of trifluoroacetic acid.

Mobile phase: See Table 1.

Table 1

Standard solution: 0.05 mg/mL of USP Tolnaftate RS in Solution A

Sample solution: Nominally 0.05 mg/mL of tolnaftate prepared as follows. Weigh and transfer a quantity of Cream equivalent of 2.5 mg of tolnaftate into a 50-mL volumetric flask and add 30 mL of Solution A. Vortex for 5 min and heat the flask in a water bath at 50° for 1.5 h. Cool to room temperature and dilute with Solution A to volume. Place the volumetric flask in the refrigerator for 30 min and centrifuge at 8000 rpm for 10 min at 4°. Pass a portion of the cold supernatant through a suitable filter of 0.45-µm pore size and discard the first 2 mL.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 254 nm. For Identification B, use a diode array detector in the range of 200–400 nm.
• Column: 4.6-mm × 15-cm; 5-µm packing L1
• Temperatures
• Autosampler: 4°
• Column: 30°
• Flow rate: 1 mL/min
• Injection volume: 10 µL

System suitability

• Sample: Standard solution
• Suitability requirements
• Tailing factor: NMT 2.0
• Relative standard deviation: NMT 1.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of tolnaftate (C₁₉H₁₇NOS) in the portion of Cream taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of tolnaftate from the Sample solution

rₛ = peak response of tolnaftate from the Standard solution

Cₛ = concentration of USP Tolnaftate RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of tolnaftate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Minimum Fill 〈755〉: Meets the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Tolnaftate RS